Evaluation of a new rapid anti‐<scp>H</scp>b<scp>F FITC</scp> assay, <scp>T</scp>rillium <scp>Q</scp>uik<scp>Q</scp>uant, for detection and quantitation of foetomaternal haemorrhage

Abstract

INTRODUCTION: This study evaluated a new product for flow cytometric foetomaternal haemorrhage (FMH) quantitation, Trillium QuikQuant anti-HbF FITC kit (Trillium Diagnostics, USA), in comparison with the Millipore anti-HbF FITC method. METHODS: Blood from 67 antenatal or postpartum RhD-negative women together with 108 samples spiked with 0.2%, 0.4%, 0.6%, 2%, 4%, 5%, 6%, 8% and 10% of foetal red cells were analysed by both methods. RESULTS: Results for both methods were linear to 10% foetal red cells. Analysis using the Wilcoxon test found that there was no difference between the paired results of Trillium QuikQuant and the expected values of the spiked samples (P = 0.48). In contrast, Millipore anti-HbF FITC gave statistically higher results compared with both the expected values and Trillium QuikQuant anti-HbF FITC (P = 0.0003 and P < 0.0001, respectively). The Bland-Altman plot for Trillium QuikQuant showed a mean difference of only 0.06% below the expected values, whilst Millipore was 0.13% above. The analysis time with Trillium QuikQuant was approximately 40 min, requiring significantly less hands-on time than the Millipore method that required an additional four wash steps. CONCLUSION: Trillium QuikQuant is a new precise, accurate and rapid flow cytometric kit method for the quantitation of FMH in both the antenatal and postpartum period.